After touting Gazyva's potential in lupus, Roche nabs 'breakthrough' ahead of PhIII
Roche’s effort to introduce its blood cancer drug Gazyva to the immunology space just got a boost from the FDA.
Regulators have granted breakthrough designation to the use of the CD20-targeting antibody in lupus nephritis, a life-threatening manifestation of systemic lupus erythematosus in the kidney. Up to 60% of all people with lupus — disproportionately women — develop such inflammation in the kidney, the Lupus Foundation of America estimates.
Immunosuppressants such as mycophenolate mofetil or mycophenolic acid and corticosteroids are the current standard of care, but Roche CMO Sandra Horning noted that new treatment options are needed. In a Phase II study, investigators showed that adding Gazyva to the regimen helped a larger proportion of patients achieve complete renal response at one year.
A Phase III trial is slated to begin next year.
While Gazyva has previously been positioned as a potential successor to the aging Rituxan franchise, Roche recently highlighted its potential in lupus on its Pharma Day earlier this week.
The therapeutic pivot is part of a larger attempt to reduce Roche’s dependence on the established — and highly profitable — oncology portfolio in favor of novel drugs and targets, Cowen analyst Steve Scala wrote in a note.
Roche made clear that margins were not suffering through the launch of new growth drivers Ocrevus (multiple sclerosis) and Hemlibra (hemophilia). Robust uptake of both drugs has buoyed the topline while new productivity initiatives saved costs, exemplified by successful launches despite adding no head count to sales forces. The company hopes to replicate this success when launching into NMOSD with satralizumab, IBD with etrolizumab, SMA with risdiplam, Huntington’s with ASO-HTT, and lupus with Gazyva.
The drug has been approved to treat chronic lymphocytic leukemia and follicular lymphoma, with or following chemo. Its 2018 sales totaled CHF 390 million (roughly $392 million).
